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Smiths Medical recalls syringe pumps for software malfunction

Dive Brief The Food and Drug Administration has categorized Smiths Medical’s correction of more than 50,000 syringe pumps in the U.S. as a Class I recall. Smiths Medical, which became part of ICU Medical in a $2.35 billion takeover in January 2022, wrote to customers in December after identifying software problems that could cause its Medfusion 4000 syringe pump to fail. There has been one reported injury linked to the problem. The recall is the latest in a series of regulatory actions related to Smiths Medical. ICU Medical was still working to resolve a warning letter sent to Smiths Medical in 2021 and was facing falling sales of acquired products as of Sept. 30, according to its most recent quarterly results filing. Dive Insight The Class I recall applies to Model 4000 syringe pumps distributed between November 2010 and July 2023. The devices are designed to administer fluids such as ...
- Source: drugdu
- 134
- February 17, 2024
Smiths Medical recalls syringe pumps for software malfunction

Dive Brief The Food and Drug Administration has categorized Smiths Medical’s correction of more than 50,000 syringe pumps in the U.S. as a Class I recall. Smiths Medical, which became part of ICU Medical in a $2.35 billion takeover in January 2022, wrote to customers in December after identifying software problems that could cause its Medfusion 4000 syringe pump to fail. There has been one reported injury linked to the problem. The recall is the latest in a series of regulatory actions related to Smiths Medical. ICU Medical was still working to resolve a warning letter sent to Smiths Medical in 2021 and was facing falling sales of acquired products as of Sept. 30, according to its most recent quarterly results filing. Dive Insight The Class I recall applies to Model 4000 syringe pumps distributed between November 2010 and July 2023. The devices are designed to administer fluids such as ...
- Source: drugdu
- 187
- February 17, 2024
GSK to license Elsie’s oligonucleotide discovery platform

GSK has exercised its option for a non-exclusive licence to Elsie Biotechnologies’s discovery platform to detect and develop new oligonucleotides. The move follows a successful research collaboration initiated last year, aimed at harnessing the platform’s capabilities for oligonucleotide drug discovery. In July 2023, GSK and Elsie Biotechnologies entered a research collaboration. Their goal was to advance the discovery and development of new oligonucleotides, prioritising efficacy, safety and delivery. The partnership leveraged GSK’s expertise in deoxyribonucleic acid (DNA)-encoded library technologies and Elsie’s drug discovery platform. During the initial research period, the companies focused on exploring the full potential of Elsie’s platform. GSK’s option for a non-exclusive licence was part of the original agreement, allowing for the application of Elsie’s discovery platform and chemistry technologies in GSK’s oligonucleotide drug discovery projects. Elsie is entitled to receive a licence payment from GSK, along with future milestone payments on meeting development and commercial goals ...
- Source: drugdu
- 137
- February 17, 2024
FDA approves Eicos’s Aurlumyn for severe frostbite treatment

The US Food and Drug Administration (FDA) has approved Eicos Sciences’s Aurlumyn (iloprost) injection, a new treatment for adults with severe frostbite to lower the risk of amputation of fingers or toes. Aurlumyn contains iloprost, a vasodilator that opens blood vessels and stops blood clotting, as its active ingredient. The efficacy of iloprost in treating severe frostbite was established through an open-label controlled trial in 47 adult subjects. Participants were randomised into three groups, with group one receiving iloprost intravenously for six hours daily for up to eight days along with aspirin and standard of care. Groups two and three were administered other medications, with and without iloprost, which are not approved for frostbite treatment. The trial’s primary efficacy measure was bone scans on day seven following the frostbite incident to predict the need for amputation. The scans showed that none of the subjects who received iloprost alone (group one) ...
- Source: drugdu
- 127
- February 17, 2024
People with chest pain more likely to develop heart and circulatory diseases

Around one million adults in the UK visit their GP every year due to chest pain Researchers from Keele University have identified the key risk factors of people with unattributed chest pain developing heart and circulatory diseases. The study, published in the European Journal of Preventative Cardiology, was funded by the British Heart Foundation (BHF). Every year, around one million adults in the UK visit their GP due to chest pain and many will not receive a diagnosis, with only a few receiving preventative treatments. Previous research has shown that people living with unattributed chest pain have a higher risk of experiencing future heart health problems compared to those without. Researchers developed risk calculators to identify people at a high risk of developing future heart and circulatory diseases, and to pinpoint the key factors that influence that risk. The team used anonymised information from the health records of over 600,000 ...
- Source: drugdu
- 113
- February 17, 2024
Study suggests heart stress test could transform patient diagnosis

The EST identified 30% of patients with a blood supply/demand mismatch Researchers from King’s College London (KCL) have revealed that the revival of a heart stress test was successful when put to the test against contemporary standards in heart care. Published in the Journal of American College of Cardiology, the electrocardiogram exercise stress test (EST) was accurate in identifying abnormalities in the heart’s blood supply. Previously, the EST was a popular way of assessing patients with angina – attacks of chest pain caused by reduced blood flow to the heart. The test required a patient to exercise on a treadmill or stationary bike while a cardiologist distinguished whether the blood supply to the heart muscle matched the demand during physical stress. However, due to its perceived inaccuracies, the EST test fell out of favour. KCL researchers, however, questioned this after discovering that an abnormal EST was successful in picking up ...
- Source: drugdu
- 108
- February 17, 2024
CRISPR Test Diagnoses Mpox Faster Than Lab-Based PCR Method

Mpox, formerly known as monkeypox, is a rare viral disease transmitted through physical contact and typically presents mild symptoms like fever, rash, and swollen lymph nodes, though severe cases can require medical intervention. Due to its contagious nature, prompt testing is crucial for isolation and treatment purposes. Current mpox testing requires laboratory equipment and may take hours to yield results. Now, new research suggests a way for faster mpox testing that could be done in any clinic. Researchers at Pennsylvania State University (University Park, PA, USA) have utilized CRISPR, the groundbreaking gene-editing technology, to develop a faster mpox test. For their study, the team designed a genetic sequence with an attached reporter specifically targeting the mpox virus. The test employs programmable CRISPR RNA that binds to the target and a protein called Cas12a, which together cleaves the reporter to produce fragments of varying sizes. Using nanopore sensing technology, these reporter ...
- Source: drugdu
- 126
- February 16, 2024
Portable Rapid PCR Diagnostic to Detect Gonorrhea and Antibiotic Susceptibility

Gonorrhea, ranked as the second most reported bacterial sexually transmitted infection (STI), affected approximately 82 million people globally in 2020. The infection can lead to severe health complications, including pelvic inflammatory disease, chronic pelvic pain, and infertility. Untreated gonorrhea may progress to the bloodstream, posing a life-threatening risk and increasing the likelihood of HIV infection. Many cases go unreported due to asymptomatic patients, implying that the actual burden of the disease may be significantly higher. Now, a rapid test aims to identify gonorrhea and also determine its antibiotic susceptibility. Visby Medical (San Jose, CA, USA) has been awarded up to USD 1.8 million by CARB-X (Boston, MA, USA) for the development of a portable rapid polymerase chain reaction (PCR) diagnostic to identify the presence of Neisseria gonorrhoeae (NG), the pathogen responsible for gonorrhea, and ascertain its susceptibility to ciprofloxacin. Ciprofloxacin was once a primary oral antibiotic for treating NG but ...
- Source: drugdu
- 149
- February 16, 2024
US lawmakers urge administration to take action against Wuxi

In a letter to the US Departments of Treasury, Defense, and Commerce, four lawmakers have expressed their concerns regarding biotech WuXi AppTec and its subsidiary WuXi Biologics’ supposed ties to the Chinese military. The 12 February letter from Chairman Mike Gallagher (R-WI), Senator Bill Hagerty (R-TN), Ranking Member Raja Krishnamoorthi (D-IL), and Senator Gary Peters (D-MI) asked that the administration add Wuxi to US government control lists given the biotech’s alleged ties to the Chinese Communist Party (CCP) and involvement in the CCP genocide of Uyghurs in Xinjiang, Reuters first reported. In addition, the letter alleges that the biotech is “closely affiliated” with the People’s Liberation Army (PLA), claiming that the biotech’s chairman and CEO Dr. Li has “personally commended CCP branch work in the company and has called on Party branches and members to play an active role in the company.” Lawmakers also claim that CEO Chen Zhisheng of ...
- Source: drugdu
- 105
- February 16, 2024
Changing protocol language and site actions are key to making trials inclusive

Changing the language used in trial protocols and continually conversing with sites are some ways by which trialists can make clinical research more inclusive of the LGBTQIA+ community, say experts. On the fourth and final day of the 2024 Summit for Clinical Ops Executives (SCOPE) Summit held in Orlando, a panel discussed the most important changes that can make clinical trials more inclusive of the community. Shir Netanel, associate director of patient advocacy and clinical trial advocacy for Janssen, spoke about her experience with the company launching a transgender-inclusive Phase III trial for prostate cancer. Netanel mentioned how changing the language to be gender neutral, for example, allowed the protocol and eligibility criteria to include any patients who are affected with prostate cancer, regardless of their gender. Additionally, Janssen has also created and deployed a toolkit at trial sites to help investigators be more inclusive, she added. Michel Reid, head ...
- Source: drugdu
- 96
- February 16, 2024

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